Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-29 @ 11:51 AM
Study NCT ID:
NCT05152056
Status:
COMPLETED
Last Update Posted:
2021-12-10
First Post:
2021-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI and Fine Needle Aspiration in the Diagnosis of Parotid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010307', 'term': 'Parotid Neoplasms'}], 'ancestors': [{'id': 'D012468', 'term': 'Salivary Gland Neoplasms'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010305', 'term': 'Parotid Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-09', 'studyFirstSubmitDate': '2021-11-26', 'studyFirstSubmitQcDate': '2021-11-26', 'lastUpdatePostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study the performance of diffusion and perfusion MRI sequences in the diagnosis of parotid tumors on a large series of cases', 'timeFrame': 'Files analysed retrospectively from January 1, 2009 to June 30, 2020 will be examined]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parotid Tumor', 'Diffusion MRI', 'Perfusion MRI', 'Aspiration cytology', 'Fine-needle biopsy'], 'conditions': ['Parotid Tumor']}, 'descriptionModule': {'briefSummary': 'What value is given to MRI diffusion and perfusion sequences in the diagnosis of parotid tumors? Is a fine needle aspiration associated with MRI systematically necessary? The aim of the research is to study the performance of diffusion and perfusion MRI sequences in the diagnosis of parotid tumors on a large series of cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Minor and major subjects operated for a parotid tumor at Strasbourg University Hospital between January 2009 and June 2020 and having had in the preoperative assessment an MRI of the parotid, also carried out at the Strasbourg University Hospital.', 'eligibilityCriteria': 'Inclusion criteria:\n\n* Major subject (≥18 years old)\n* Minor subject (\\<18 years old)\n* Operated for a parotid tumor at Strasbourg University Hospital between January 2009 and June 2020\n* Having had in the preoperative assessment an MRI of the parotid, also carried out at the Strasbourg University Hospital.\n* Subject (and / or his parental authority) not having expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.\n\nExclusion criteria:\n\n* Subject (or his parents) who expressed his (their) opposition to participating in the study\n* Lack of pathological or MRi results\n* Subject under guardianship, curatorship or safeguard of justice'}, 'identificationModule': {'nctId': 'NCT05152056', 'acronym': 'Parotid', 'briefTitle': 'MRI and Fine Needle Aspiration in the Diagnosis of Parotid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Role of MRI and Fine Needle Aspiration in the Diagnosis of Parotid Tumors', 'orgStudyIdInfo': {'id': '8454'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': "Service d'ORL et de Chirurgie Cervico-Faciale - Hôpitaux Universitaires de Strasbourg", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}